Position Summary:

The Senior Manager, Quality Assurance, Drug Product focus, will report to the Director, Quality Assurance. The Senior Manager is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Products and Devices meet regulatory requirements and internal Vera standards.

Responsibilities:

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements.
• Responsible for implementing strategies and tactics to promote and maintain GxP compliance.
• Lead quality aspects of and provide quality support on DP tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of commercial and clinical DP/ combination products.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc.
• Provides assistance during both internal and regulatory agency audits as required
  Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Lead for Quality Agreement with external partners.
• Support product lifecycle and continued process verification.
• Availability for 10-20% travel, both domestically and internationally.

Qualifications:

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.
• Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors.
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.
• Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus.

Euclid: Where Projects Take Shape

Reporting to the Senior Project Manager, the Project Manager, Asset Management will focus on optimizing the performance and profitability of our client’s utility-scale solar (PV) and energy storage (BESS) assets. This role will be starting out on a contract basis. 

This individual will manage both generation-based and dispatchable assets, monitoring operational performance, analyzing market opportunities, managing vendor relationships, ensuring compliance, and supporting financial and operational reporting. The ideal candidate will have a blend of analytical, technical, and market expertise to drive value of operating projects.

Who We Are

At Euclid, we’re on a mission to accelerate the world’s transition to renewable energy so that we can decarbonize the planet as fast as possible. We empower renewable energy teams to accomplish in days what typically takes weeks.

We care about doing meaningful work, delivering real value and results to our customers. We’re passionate about solving real problems by focusing on what truly matters. We’re passionate about our work, and we’re building products and services that our customers genuinely love and trust. We’re not afraid to think big and be bold, as we’re building not only a future we believe in but a workplace culture that we’re proud to be a part of.

What You’ll Do

Asset Performance Management

• Monitor energy storage asset performance, ensuring systems operate above contractual obligations.
• Oversee troubleshooting and resolution of technical issues with battery management systems, inverters, and other storage components.
• Analyze operational data to identify underperformance and collaborate with O&M and LTSA providers, and other partners to resolve issues.
• Coordinate with O&M and LTSA providers to ensure efficient preventive and predictive maintenance.
• Develop and refine models to assess lifecycle costs and profitability of storage assets.
• Identify cost-savings opportunities and build business cases to support.
• Monitor PV plant performance (Performance Ratio, Availability) against P50/P90 energy yield projections.
• Analyze solar-specific data such as DC/AC ratios, inverter clipping, and degradation rates to identify underperformance.
• Oversee troubleshooting for PV-specific components like trackers, modules, and combiner boxes.

Market Optimization and Dispatch Oversight

• Analyze market data to ensure revenue opportunities, such as energy arbitrage or ancillary services, are performing above contractual obligations.
• Provide oversight to development and implementation of optimization strategies for energy storage dispatch.
• Manage revenue streams for PV-only assets, including PPA compliance, REC (Renewable Energy Certificate) tracking, and merchant solar exposure.
• Ensure accurate forecasting for solar generation to minimize imbalance charges in wholesale markets.

Data Analysis and Reporting

• Serve as the go to for asset questions and analysis.
• Develop and maintain performance dashboards and KPIs for energy storage assets.
• Prepare performance and financial reports for internal stakeholders, investors, lenders, and regulators.
• Prepare or support all sustainability reporting requirements.

Contract and Compliance Management

• Support or oversee compliance with all operational project documents
• Manage contracts with O&M providers, equipment vendors, and software service providers.
• Ensure compliance with interconnection agreements, market rules, and regulatory requirements.
• Oversee warranty claims and ensure vendor obligations are met.

Financial and Budget Management

• Support budgeting and forecasting for operational expenses and capital improvements.
• Support and oversee monthly and quarterly variance reporting to tell a clear story of financial and operational asset performance.
• Support tracking model results and associated story for investor and lender reporting.
• Analyze and report on the impacts of ITC vs. PTC on the asset's long-term cash flow and tax equity structures.
• Support tracking and reporting for solar-specific environmental attributes and sustainability metrics

Stakeholder Collaboration

• Serve as a point of contact for internal and external stakeholders, including investors, utilities, and market operators (as needed)
• Collaborate with internal team to evaluate new energy storage project opportunities or expansions.

Who You Are

• You have 4–6 years of experience in utility-scale solar PV generation and energy storage or energy market analytics with a dispatchable asset focus.
• Strong understanding of PV system design, tracking systems, bifacial module performance, energy storage technologies, market dynamics, and dispatch optimization strategies.
• Experience in wholesale energy markets (e.g., CAISO, PJM, ERCOT) is a plus.
• Proficiency in data analysis tools (e.g., Python, R, Excel, Power BI).
• Experience with PV monitoring platforms (e.g., AlsoEnergy, Power Factors) and solar modeling tools.
• Familiarity with energy storage control platforms, such as battery management systems or SCADA.
• Experience with project documents and contracts pertaining to utility-scale PV and BESS plants, including EPC warranties, Performance Guarantees, and long-term land leases.
• Excellent organizational and project management skills.
• Bachelor’s degree in engineering, finance, energy systems, or a related field.
• Advanced degree (MBA, MS) is a plus.

Why You’ll Love Working With Us

• ⌨️ Remote work, forever!
• 🪄 Competitive benchmarked compensation
• 🩺 Health and Retirement Benefits
• 🌴 Flexible Time Off
• 🚀 Exciting, mission-driven work that has impact
• 🧳Regular Company offsites

How You’ll Be Compensated

The starting base pay for this role is between $135,000-$150,000. The base pay depends upon many factors, such as education, experience, and location. The base pay range is subject to change and may be modified. This role may also be eligible for equity and benefits.

We are committed to building an inclusive working environment and doing our part to create a more equitable world. We strongly encourage applicants from underrepresented and/or historically marginalized communities to apply.